Safety Systems Analyst II

Duties:
Product of Role Responsible for supporting the maintenance of the Pharmacovigilance (PV) database. Responsible for supporting and performing PV database data retrieval activities. Primary Responsibilities Execution of weekly, monthly and ad hoc reports from the PV database Preform all required Quality Control (QC) and complete documentation Assist with the execution and verification of Ethics Committee and Health Authority Periodic outputs Maintain and distribute the Study Configuration Spreadsheet Maintain and distribute applicable sections of the Data Entry Conventions and associated appendices Track the development, testing, implementation and closure of all PV Systems requests Assist PV Systems Director with the following activities: maintenance and delivery of systems supporting the PV business unit, the primary focus is the Argus Safety Systems. monitoring of PV System vendor activities and ensuring compliance with contractual expectations maintaining documentation of system configuration and all subsequent changes validates and implements annual, periodic and ad-hoc reports in the Drug Safety systems maintaining the processes for systems in compliance with regulatory requirements and company standards.

Skills:
Education/Experience/Skills At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety Database Attention to detail, Critical thinking, Creative problem-solving, Collaborative approach, Proficient Computer Skills, including Microsoft Word and Excel Knowledge of Drug Safety and Pharmacovigilance function English (fluent verbal and written).

Education:
Education/Experience/Skills At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety Database Attention to detail, Critical thinking, Creative problem-solving, Collaborative approach, Proficient Computer Skills, including Microsoft Word and Excel Knowledge of Drug Safety and Pharmacovigilance function English (fluent verbal and written)